Clinical Research Coordinator – Ethics & Regulatory Affairs

Do you want to work for a world-renowned research institute that pushes the boundaries of biomedical science and health research Right here in Montreal! At the Research Institute of the McGill University Health Centre (RI-MUHC) you can be part of an organization focused on scientific discovery and innovation in patient-centered medicine. Join us today and make a difference!

RESEARCH INSTITUTE OF THE MUHC
The Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and hospital research centre. Located in Montreal Quebec the Institute is the research arm of the McGill University Health Centre (MUHC) affiliated with the Faculty of Medicine at McGill University. The RI-MUHC is supported in part by the Fonds de recherche du Québec - Santé (FRQS).

Position summary
Department / Research Program: CVIS Research

The Chronic Viral Illness Service Research team has an active research program conducting numerous clinical trials each year to provide innovative research to their patients. Under the immediate supervision of the CVIS Research Director and the CVIS Clinical Research Manager the incumbent will be directly involved in several PI-Initiated and industry clinical trials and research studies related to chronic viral illnesses such as HIV HBV HCV STIs and liver diseases. The Clinical Research Coordinator Ethics & Regulatory Affairs will complete the below listed tasks at the Chronic Viral Illness Service of the McGill University Health Center.

General Duties
The position includes the following tasks but are not limited to:

- Collaborates with internal (Researchers research staffs pharmacy Research institution department Quality Assurance Hospital department and Division clinic staff) and external ( CATALIS other research sites Pharmaceutical Industry Sponsor CROs etc.) stakeholders.

Ethics activities
-Responsible for Ethics initial preparation and submission via NAGANO up to REB full approval and MUHC Authorization
-Review start-up package for completeness
-Prepare study ICFs as per the MUHC REB templates and obtain Sponsor approval
-Primary point of contact for research ethics committees
-Follow-up with Feasibility assessment
-Organize Site Initiation Visit
-Responsible for ongoing ethics activities submission and approval as amendments notifications annual renewal close-out report deviations Serious Adverse Events etc.

Regulatory affairs activities
-Act as a resource for investigators and research staff on clinical trials regulations GCP HCD5 SOPs etc.
-Maintain Regulatory documentation and Investigator Site Files (ISF)
-Maintain research team regulatory certifications and Master Regulatory files
-Assure timely completion and signatures of regulatory documents for trials
-Prepare training synopsis & training logs for trials initiation and amendments
-Responsible for Delegation of Authority logs.

Additional tasks
-Organize Site Initiation Visits and other trials trainings
-Optimize study start-up and amendment approval timelines
-Follow-up/meet with the CRA during/after monitoring visits
-Assist with Investigator Initiated Study ethics and regulatory affairs
-Act as a resource for staff with questions regarding the review process and requirements
-MSSS multicentric submission with other sites in Quebec
-Comply with Good Clinical Practice Health Canada division 5 MUHC Standard Operation Procedures etc.
-Respect different concurrent timelines
-Prepare and lead institutional sponsor and health agencies monitoring and audits.

/ Experience

Education: Bachelors Degree
Field of Study: Health sciences Ethics Public Health Research on human pharmacology
Other education considered an asset for this position: Certification in Ethics GCP HCD5 other research program clinical trials certification

Work Experience: 2 years in clinical trials field

This position requires an advanced knowledge of oral and written French.
An advanced knowledge of oral and written English is required as the position requires regular and complex contact with researchers or international students who are exclusively proficient in English. The position also requires complex writing or in-depth analysis of documents in English related to a research project.

Must be professional possess a high degree of efficiency and self-motivation and have a strong work ethic and respect of confidentiality
Excellent communication and interpersonnel skills
Detail oriented
Demonstrates high organization and adaptability skills
High tolerance to work under pressure and with multiple short deadlines
Capacity to work autonomously or with teams with minimum supervision
Proficiency in Microsoft Office (Word Excel Teams Outlook) and Adobe.
Experience with NAGANO and ethics submission an asset.

Status: Temporary full time (35-hour workweek)
Pay Scale: Commensurate with education and experience
Work Shift: Monday to Friday 8:30am to 4:30pm
Work Site: Glen Site 1001 Decarie Blvd.

***If you wish to include a cover letter please attach it with your resume in one document. ***

Why work with us

4-week vacation 5th week after 5 years
Bank of 12 paid days (personal days and days for sickness or family obligations)
13 paid statutory holidays
Modular group insurance plan (including gender affirmation coverage)
Telemedicine
RREGOP (defined benefit government pension plan)
Training and professional development opportunities
Child Care Centres
Corporate Discounts (OPUS Perkopolis)
Competitive monthly parking rate
Employee Assistance Program
Recognition Program
Flex work options and much more!



learn more about our benefits please visit IS NOT A HOSPITAL POSITION.

The Research Institute of the McGill University Health Centre hires on the basis of merit and is strongly committed to equity diversity and inclusion within its community. We welcome applications from all qualified candidates who self-identify as members of racialized groups/visible minorities women Indigenous persons persons with disabilities ethnic minorities and 2SLGBTQIA persons. We also welcome candidates with the skills and knowledge to productively engage with diverse communities. Persons with disabilities who anticipate needing accommodations for any part of the application process may confidentially contact